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Lupin Pharmaceuticals Inc.

Lupin Pharmaceuticals Inc. Recalls

All product recalls associated with Lupin Pharmaceuticals Inc..

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Recall Summary

Total Recalls

1000

Past Year

303

Class I (Serious)

Most Recent

Nov 2025

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 1521–1540 of 4747 recalls

Metformin Hydrochloride Extended-Release 1000mg (Lupin) – NDMA Impurity (2020)

CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level

Class IIModerate

FDAJul 7, 2020Nationwide• Lupin Pharmaceuticals Inc.

Clonazepam Orally Disintegrating Tablets (Sun Pharmaceutical) – Cross Contamination (2020)

Cross contamination with other products - OOS discovered during routine stability testing for highest unknown impurity later identified as clozapine

Class IIILow

FDAJul 6, 2020Nationwide• SUN PHARMACEUTICAL INDUSTRIES INC

Metformin Hydrochloride Extended-Release 750mg (Granules) – NDMA Impurity (2020)

CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level

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Class IIModerate

FDAJul 3, 2020Nationwide• Granules Pharmaceuticals Inc

Bio AAA Advance Hand Sanitizer (AAA Cosmetica) – CGMP Deviations (2020)

CGMP Deviations

Class IIModerate

FDAJul 2, 2020Nationwide• AAA Cosmetica, SA de CV

Bio AAA Advance Hand Sanitizer (AAA Cosmetica) – Methanol Contamination (2020)

Chemical Contamination: Product contains methanol.

Class IHigh

FDAJul 2, 2020Nationwide• AAA Cosmetica, SA de CV

Cefdinir Oral Suspension (Lupin) – Superpotent Drug Result (2020)

Superpotent Drug: Out-of-specification (OOS) result observed in an assay test of retention samples.

Class IIModerate

FDAJul 2, 2020Nationwide• Lupin Pharmaceuticals Inc.

Lidothol Patch (Preferred Pharmaceuticals) – Record Misplacement (2020)

CGMP Deviations: Contract Manufacturing Organization (CMO) misplaced/lost batch records and test results for the recalled batch.

Class IIModerate

FDAJul 1, 2020Nationwide• Preferred Pharmaceuticals, Inc.

Siemens Healthcare Diagnostics, Inc.: DCA Vantage Handheld Barcode Scanner - Zebra Model - Mode...

If DCA Vantage Analyzer is configured to run Code 39 with check digit, the scanner is not confirming the integrity of read barcode data using the check digit. Also, if DCA Vantage Analyzer is configured to run Code 39 with check digit and an operator erroneously scans a Code 39 barcode without a check digit, the scanner incorrectly sends the code and the last character is removed.

FDAJun 30, 2020Nationwide• Siemens Healthcare Diagnostics, Inc.

DOMETIC CFF Equipment Recall: EQUIPMENT:ELECTRICAL

Fire/Burn Risk

Dometic Corporation (Dometic) is recalling certain CFX3 Series chest refrigerators (models CFX3 35, CFX3 45, CFX3 55IM, CFX3 75DZ, CFX3 95DZ and CFX3 100), and CFF Series chest refrigerators (models CFF 35, and CFF 45). The protection device on the electrical circuit may fail when the refrigerator is connected to both AC and DC power, allowing the AC/DC power supply to back feed through some or all of the other appliances (such as the air conditioner, water pump, lights, furnace, etc.) that are connected to the 12V DC system. A voltage overload may result, causing DC appliances on the same circuit to fail.

NHTSAJun 18, 2020Nationwide• DOMETIC

Chembio Diagnostics, Inc: Chembio DPP COVID-19 IgM/IgG System- Rrapid immunochromat...

FDA revocation of the Emergency Use Authorization due to performance issues

FDAJun 18, 2020Nationwide• Chembio Diagnostics, Inc

Chembio Diagnostics, Inc: Chembio DPP Micro Reader for use with the DPP COVID-19 Ig...

FDA revocation of the Emergency Use Authorization due to performance issues

FDAJun 18, 2020Nationwide• Chembio Diagnostics, Inc

Chembio Diagnostics, Inc: Chembio DPP Micro Reader II for use with the DPP COVID-19...

FDA revocation of the Emergency Use Authorization due to performance issues

FDAJun 18, 2020Nationwide• Chembio Diagnostics, Inc

Metformin Extended Release (Preferred Pharmaceuticals) – NDMA Impurity (2020)

CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.

Class IIModerate

FDAJun 17, 2020FL, IN• Preferred Pharmaceuticals, Inc.

Heparin Sodium (SCA Pharmaceuticals) – Subpotent Medication (2020)

Subpotent Drug: Out-of-Specification potency results at the 30-day stability timepoint.

Class IIModerate

FDAJun 16, 2020CA, IN, PA• SCA Pharmaceuticals

Metformin Extended Release (Lupin Pharmaceuticals) – NDMA Impurity (2020)

CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level

Class IIModerate

FDAJun 11, 2020Nationwide• Lupin Pharmaceuticals Inc.

Irinotecan Injection (Hikma Pharmaceuticals) – Crimp Defect (2020)

Defective Container: Customer complaints received of a crimp defect while removing the flip-cap during use.

Class IIModerate

FDAJun 11, 2020Nationwide• Hikma Pharmaceuticals USA Inc.

Irinotecan Injection (Hikma Pharmaceuticals) – Crimp Defect (2020)

Defective Container: Customer complaints received of a crimp defect while removing the flip-cap during use.

Class IIModerate

FDAJun 11, 2020Nationwide• Hikma Pharmaceuticals USA Inc.

Aripiprazole Tablets (Alembic Pharmaceuticals) – Labeling Mixup (2020)

Labeling: Label mix up: Bottles labeled as aripiprazole 2 mg, 30 count had aripiprazole 5 mg tablets, 100 count.

Class IIModerate

FDAJun 10, 2020Nationwide• Alembic Pharmaceuticals Limited

Siemens Healthcare Diagnostics, Inc.: ADVIA Chemistry Calibrator

Calibration errors have been observed with the Total and Direct Bilirubin assays when using Chemistry Calibrator lot 534177 for ADVIA Chemistry and lot 534179 for Atellica CH.

FDAJun 5, 2020Nationwide• Siemens Healthcare Diagnostics, Inc.

Siemens Healthcare Diagnostics, Inc.: Atellica CH Chemistry Calibrator

Calibration errors have been observed with the Total and Direct Bilirubin assays when using Chemistry Calibrator lot 534177 for ADVIA Chemistry and lot 534179 for Atellica CH.

FDAJun 5, 2020Nationwide• Siemens Healthcare Diagnostics, Inc.